510(k) Report

FDA applicant

Novalign Orthopaedics, Inc.

Memphis, TN1 decision2009–20090 recalls

FDA records 1 decision for Novalign Orthopaedics, Inc. (Memphis, TN) in 2009: 1 510(k) clearance. All are in product code HSB (Rod, Fixation, Intramedullary And Accessories). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Novalign Orthopaedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Novalign Orthopaedics, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HSBRod, Fixation, Intramedullary And Accessories1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K083458Intramedullary Fixation Rod (Ifs)Novalign Orthopaedics, Inc. · 20091cites it

What has FDA decided for it lately?

  • K083458Intramedullary Fixation Rod (Ifs)Novalign Orthopaedics, Inc. · 2009

The one decision as Novalign Orthopaedics, Inc. →